- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04292418
Predictors of Rejection in Pediatric Kidney Transplantation
February 29, 2020 updated by: Aya Khalifa, Assiut University
Renal transplantation is the best option among the end-stage renal disease (ESRD) treatment alternatives, It is also relatively less expensive than dialysis.
Allograft rejection is a major issue in kidney transplantation.
Rejection is classified as acute or chronic, cellular or antibody-mediated.Children with kidney transplants require life-long immunosuppressive therapy to prevent rejection of the allograft
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The most common medication regimen in the United States includes the combination of corticosteroid (eg, prednisone), a calcineurin inhibitor (or CNI, most commonly tacrolimus), and an antimetabolite such as mycophenolate mofetil (MMF).
Cyclosporine and azathioprine are less commonly used for maintenance immunosuppression Tacrolimus level is a main maintenance immunosuppressant in kidney transplantation .In the early days of posttransplant period, hematocrit concentrations are generally low and increase significantly as patient recovers.
Because tacrolimus binds strongly to erythrocytes in systemic circulation, the effect of hematocrit on distribution of tacrolimus is important for the methods used to measure tacrolimus concentrations ,hematocrit correction could be a step towards improvement of tacrolimus dose individualization Thearputic drug monitoring of MPA has been proposed to optimize drug dosage avoiding potential hematologic and digestive side effects .MPA monitoring is generally based on the determination of the plasma MPA trough concentration (C0) .
Study Type
Observational
Enrollment (Anticipated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aya Khalifa, master degree
- Phone Number: 00201016228446
- Email: dr.ayaahmedkhlifa@gmail.com
Study Contact Backup
- Name: Doaa Salah, MD
- Phone Number: 002001205551924
- Email: doaamsalah2010@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Paediatric living donor kidney transplant recipients (aged 1-18 years)
Description
Inclusion Criteria:
- Paediatric living donor kidney transplant recipients (aged 1-18 years)
- patients received standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug [mycophenolate mofetil (MMF) and steroids
- recipients with biopsy proven acute rejection in the studied group.
Exclusion Criteria:
- patients on cyclosporine
- patients with active infection and dehydration
- Patients who received multiorgan transplantation Non cooperative patient will be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
study group 1
(rejector group )include Paediatric living donor kidney transplant recipients (aged 4-18 years) at least 35 child recieving standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug [mycophenolate mofetil (MMF) and steroids, with biopsy proven acute rejection in the study group 1 measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test
|
measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test for study group 1 and study group 2
|
study group 2
the second group (non rejector group ) include Paediatric living donor kidney transplant recipients (aged 4-18 years) recieving standard triple drug immunosuppression consisting tacrolimus an antiproliferative drug [mycophenolate mofetil (MMF) and steroids, with biopsy proven acute rejection in the studied group at least 35 child measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test in the study group 2
|
measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test for study group 1 and study group 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
predictors of rejection
Time Frame: 2 year
|
detect the potentially predictors of rejection in pediatric kidney transplant recipient
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measure corrected tacrolimus level and mycophenolic acid
Time Frame: 2 year
|
detect the role of corrected tacrolimus level in dose adjustment for better control of immunosuppressive therapy detect the role of neutrophil to lymphocytic ratio in prediction of kidney rejection Role of mycophenolic acid monitoring in prevention of rejection
|
2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bulut IK, Taner S, Keskinoglu A, Sezer TO, Kabasakal C. Pediatric Kidney Transplantation in Patients With Urologic Anomalies. Transplant Proc. 2019 Sep;51(7):2257-2261. doi: 10.1016/j.transproceed.2019.01.155. Epub 2019 Aug 7.
- Tamain M, Sayegh J, Lionet A, Grimbert P, Philipponnet C, Hazzan M, Augusto JF, Buchler M, Merlin E, Kosmadakis G, Tiple A, Pereira B, Garrouste C, Heng AE. Extracorporeal photopheresis for the treatment of graft rejection in 33 adult kidney transplant recipients. Transfus Apher Sci. 2019 Aug;58(4):515-524. doi: 10.1016/j.transci.2019.06.031. Epub 2019 Jul 22.
- Park WY, Paek JH, Jin K, Park SB, Han S. Long-term Clinical Significance of Tacrolimus Trough Level at the Early Period After Kidney Transplantation. Transplant Proc. 2019 Oct;51(8):2643-2647. doi: 10.1016/j.transproceed.2019.03.065. Epub 2019 Aug 30.
- Akbas SH, Ozdem S, Caglar S, Tuncer M, Gurkan A, Yucetin L, Senol Y, Demirbas A, Gultekin M, Ersoy FF, Akaydin M. Effects of some hematological parameters on whole blood tacrolimus concentration measured by two immunoassay-based analytical methods. Clin Biochem. 2005 Jun;38(6):552-7. doi: 10.1016/j.clinbiochem.2005.02.011.
- Krischock LA, van Stralen KJ, Verrina E, Tizard EJ, Bonthuis M, Reusz G, Hussain FK, Jankauskiene A, Novljan G, Spasojevic-Dimitrijeva B, Podracka L, Zaller V, Jager KJ, Schaefer F; ESPN/ERA-EDTA Registry. Anemia in children following renal transplantation-results from the ESPN/ERA-EDTA Registry. Pediatr Nephrol. 2016 Feb;31(2):325-33. doi: 10.1007/s00467-015-3201-8. Epub 2015 Sep 18.
- Chinnakotla S, Verghese P, Chavers B, Rheault MN, Kirchner V, Dunn T, Kashtan C, Nevins T, Mauer M, Pruett T; MNUM Pediatric Transplant Program. Outcomes and Risk Factors for Graft Loss: Lessons Learned from 1,056 Pediatric Kidney Transplants at the University of Minnesota. J Am Coll Surg. 2017 Apr;224(4):473-486. doi: 10.1016/j.jamcollsurg.2016.12.027. Epub 2017 Feb 27.
- Schijvens AM, van Hesteren FHS, Cornelissen EAM, Bootsma-Robroeks CMHHT, Bruggemann RJM, Burger DM, de Wildt SN, Schreuder MF, Ter Heine R. The potential impact of hematocrit correction on evaluation of tacrolimus target exposure in pediatric kidney transplant patients. Pediatr Nephrol. 2019 Mar;34(3):507-515. doi: 10.1007/s00467-018-4117-x. Epub 2018 Oct 30.
- Limsrichamrern S, Chanapul C, Mahawithitwong P, Sirivatanauksorn Y, Kositamongkol P, Asavakarn S, Tovikkai C, Dumronggittigule W. Correlation of Hematocrit and Tacrolimus Level in Liver Transplant Recipients. Transplant Proc. 2016 May;48(4):1176-8. doi: 10.1016/j.transproceed.2015.12.096.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
May 1, 2020
Primary Completion (ANTICIPATED)
May 1, 2020
Study Completion (ANTICIPATED)
October 1, 2021
Study Registration Dates
First Submitted
February 29, 2020
First Submitted That Met QC Criteria
February 29, 2020
First Posted (ACTUAL)
March 3, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 3, 2020
Last Update Submitted That Met QC Criteria
February 29, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Calcineurin Inhibitors
- Tacrolimus
- Mycophenolic Acid
Other Study ID Numbers
- PKTX
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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